GlaxoSmithKline is hoping it will be third time lucky and is again trying to get approval in the USA for its meningitis vaccine MenHibrix.
The drugs major has submitted additional information to the US Food and Drug Administration to supports its Biologics License Application for MenHibrix. The vaccine combines GSK's meningococcal and Hib vaccine and the proposed indication is active immunisation of infants and toddlers six weeks through 15 months for the prevention of invasive diseases caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib).
The new information represents GSK's reply to the second complete response letter it received from the FDA in September 2011, though the reasons for the rejection were not disclosed. MenHibrix had been turned down by the agency in June 2010 as well.
GSK said it will "continue to work closely with FDA as the agency continues its review".